Pharmacy and drug retail and wholesale groups say a new National Drug Code (NDC) policy being enacted by the Centers for Medicare and Medicaid Services (CMS) may block Medicare Part D benefits for many common prescription drugs that had been covered for years.

Rx groups: New NDC policy may disrupt Part D coverage

December 2nd, 2009

ALEXANDRIA, Va. – Pharmacy and drug retail and wholesale groups say a new National Drug Code (NDC) policy being enacted by the Centers for Medicare and Medicaid Services (CMS) may block Medicare Part D benefits for many common prescription drugs that had been covered for years.

Effective January 1, CMS plans to begin enforcing its nonmatched NDC list policy, meaning that any medication not appropriately registered with the Food and Drug Administration as of that date will no longer be covered under Medicare Part D.

The groups note that thousands of products are now on the nonmatched NDC list and are scheduled to be denied by Medicare Part D plans in a few weeks. These include many common prescription products for senior citizens, such as antidepressants, antibiotics, pain relievers, and blood pressure and diabetes medicines.

To minimize disruption on patients and pharmacies, the National Association of Chain Drug Stores, National Community Pharmacists Association, American Pharmacists Association, Food Marketing Institute and Healthcare Distribution Management Association have written a letter to CMS acting administrator Charlene Frizzera to voice their concerns and outline potential remedies.

"We strongly encourage you to continue outreach to manufacturers whose products are on the nonmatched list as well as Part D plans," the letter states. "We also strongly urge CMS to consider holding an open-door forum as soon as possible in order to capture concerns of all interested stakeholders. Although we have communicated with our respective supply chain partners, ultimately the manufacturer bears the responsibility to register their products appropriately with the FDA and with Part D plans to ensure their formularies and edits reflect CMS policies in a timely fashion."

In the letter, the coalition recommended that a CMS fact sheet or similar document be made available online to help pharmacists answer Part D beneficiaries' questions, since they may be denied medication they have obtained under the plan for years. They also noted that denying access to one generic drug will likely increase demand for equivalent generics, of which sufficient supply may not be readily available, which further impacts beneficiary access.

The letter also points out that some Part D plans may employ point-of-sale edits at the pharmacy level to block dispensing of unlisted drugs while others may not, frustrating patients and pharmacists. To promote consistency in implementation, the coalition suggested that CMS update its nonmatched NDC list more frequently or require plans to use the FDA’s NDC list to keep point-of-sale edits current.

In addition, the groups urged CMS to prohibit retroactive reversal of approved claims for NDCs that appear on the nonmatched list, explaining that such reversals would be unfair to pharmacies that dispensed the medication pursuant to plans' approval of claims at the point of sale.

The groups also have called on branded and generic drug manufacturers to step up their efforts to ensure their products' NDCs are registered with the FDA.